Global pharmaceutical company Lupin Limited has announced that it has received approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Loteprednol Etabonate Ophthalmic Gel, 0.38%.
The product is bioequivalent to Lotemax® SM Ophthalmic Gel by Bausch & Lomb Inc., and is indicated for the treatment of postoperative inflammation and pain following ocular surgery.
Lupin is the exclusive first-to-file applicant for this generic version, making it eligible for 180 days of generic drug exclusivity in the United States. The approved product will be manufactured at Lupin’s Pithampur facility in India.
According to IQVIA (MAT May 2025), Loteprednol Etabonate Ophthalmic Gel, 0.38% (RLD: Lotemax® SM) recorded estimated annual sales of around USD 29 million in the U.S. market.
This approval adds to Lupin’s growing U.S. generics portfolio and highlights its focus on expanding access to high-quality, affordable treatments.
